Fast Track Designation for Two Investigational mRNA-based Vaccine Candidates Against SARS-CoV-2
Anne-Lise Berthier
Biotech/Pharma/Bioproduction expert analyst - Member of G&CTI Think Tank and Polepharma
Pfizer and BioNTech announced that two of the companies’ four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against SARS-CoV-2 received Fast Track designation from the FDA. BNT162b1 and BNT162b2 are the two most advanced vaccine candidates in the BNT162 program currently being evaluated in ongoing Phase 1/2 clinical studies in the United States and Germany. Early data from the ongoing U.S. Phase 1/2 study for the product candidate BNT162b1 have been released on July 1, 2020. Early data from the German trial of BNT162b1 are expected to be released later in July.
The BNT162 program is evaluating at least four experimental vaccines, each of which represent a unique combination of messenger RNA (mRNA) format and target antigen. BNT162b1 and BNT162b2 are both nucleoside-modified RNAs, formulated in lipid nanoparticles. BNT162b1 encodes an optimized SARS-CoV-2 receptor-binding domain (RBD) antigen, while BNT162b2 encodes an optimized SARS-CoV-2 full-length spike protein antigen.
Subject to regulatory approval, the companies are expecting to start a Phase 2b/3 trial as soon as later this month and are anticipating enrolling up to 30,000 subjects. If the ongoing studies are successful, and the vaccine candidate receives regulatory approval, the companies currently expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.
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